Cleared Traditional

K790232 - AGAR

K790232 is the FDA 510(k) clearance for AGAR by Los Angeles Biological Products. It is a Class 1 Microbiology device (product code JSE) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K790232 · Los Angeles Biological Products · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1979
Decision
19d
Days
Class 1
Risk

K790232 is an FDA 510(k) clearance for the AGAR, MOTILITY-NITRATE. Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Los Angeles Biological Products (Mchenry, US). The FDA issued a Cleared decision on February 21, 1979 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Los Angeles Biological Products devices

Submission Details

510(k) Number K790232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1979
Decision Date February 21, 1979
Days to Decision 19 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 102d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSE Culture Media, Multiple Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSE Culture Media, Multiple Biochemical Test

All 39
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K790232.
API 20E REAGENT QC
K791222 · Analytical Products, Inc. · Aug 1979
TRIPLE SUGAR IRON AGAR (TSI AGAR)
K791473 · Isle Media and Sterile Products, Inc. · Aug 1979
CARBOHYDRATE FERMENTATION MEDIA
K790617 · Anaerobe Systems · Apr 1979
PLATE, LD PRESUMPTO
K781856 · Anaerobe Systems · Nov 1978
API 50 E
K770989 · Analytical Products, Inc. · Jun 1977
API 3S
K770176 · Analytical Products, Inc. · Feb 1977